CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Optic nerve ultrasounddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02786706
NCT02786706N/ACompleted

Accuracy of Optic Nerve Sheath Diameter Measurement From Ultrasound Videos Using an Image Analysis Algorithm Compared to Expert Measurement in Patients With Acute Brain Injury

University of Michigan·observational·Posted Jun 1, 2016·Updated Dec 4, 2020

In Brief

An observational study evaluating Optic nerve ultrasound for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed Summary

Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD) threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in clinical practice. The investigators goal is to develop and validate an automated image analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with blinded ONSD measurement by an expert investigator. The image analysis algorithm will then be used to measure ONSD and accuracy determined compared to the "reference standard" expert measurement.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartJul 1, 2015
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.1 years ago

Interventions

Optic nerve ultrasounddevice

All patients will undergo Optic Nerve Ultrasound (ONUS), with measurement of Optic Nerve Sheath Diameter (ONSD) by both an expert investigator as well as by the automated image analysis algorithm.